Extension tube clamp providing positive displacement

ABSTRACT

An extension set may include a clamp, which may include a housing and an actuator. The actuator may be movable between a raised position and a depressed position with respect to the housing. The actuator may include a bump profile. The extension set may include an extension tube, which may be disposed within the housing. The extension tube may include a loop. In response to movement of the actuator between the raised position and the depressed position with respect to the housing, the bump profile may progressively clamp the extension tube along the loop. The loop may facilitate an increased fluid volume flowing distally towards a catheter in response to actuating the clamp.

RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/808,119, filed on Feb. 20, 2019, and entitled EXTENSION TUBE CLAMPPROVIDING POSITIVE DISPLACEMENT, which is incorporated herein in itsentirety.

BACKGROUND

Catheters are commonly used for a variety of infusion therapies. Forexample, catheters may be used for infusing fluids, such as normalsaline solution, various medicaments, and total parenteral nutrition,into a patient. Catheters may also be used for withdrawing blood fromthe patient.

A common type of catheter is an over-the-needle peripheral IV catheter(“PIVC”). As its name implies, the over-the-needle PIVC may be mountedover an introducer needle having a sharp distal tip. The sharp distaltip may be used to pierce skin and the vasculature of the patient.Insertion of the PIVC into the vasculature may follow the piercing ofthe vasculature by the needle. The needle and the PIVC are generallyinserted at a shallow angle through the skin into the vasculature of thepatient with a bevel of the needle facing away from the skin of thepatient. Once placement of the needle within the vasculature has beenconfirmed, the clinician may temporarily occlude flow in the vasculatureand withdraw the needle, leaving the PIVC in place for future bloodwithdrawal and/or fluid infusion.

A needleless connector may be used to connect the PIVC with a medicaldevice for fluid administration or blood withdrawal. The medical devicemay include a transfusion bag, syringe, or the like. Currently, manyneedleless connectors reflux, meaning they draw blood and fluid from thevasculature into the catheter upon disconnection of the medical devicefrom the needleless connector. This connector-driven reflux is notdesirable due to the increased potential for reduced PIVC dwell times,which may result from clotting and occlusion within the PIVC. Systemsand methods described in the present disclosure can mitigate and/orovercome these drawbacks.

The subject matter claimed herein is not limited to embodiments thatsolve any disadvantages or that operate only in environments such asthose described above. Rather, this background is only provided toillustrate one example technology area where some implementationsdescribed herein may be practiced.

SUMMARY

In some embodiments, an extension set may include a clamp, which mayinclude a housing and an actuator. In some embodiments, the actuator maybe movable between a raised position and a depressed position withrespect to the housing. In some embodiments, the actuator may include abump profile. In some embodiments, the extension set may include anextension tube, which may be disposed within the housing. In someembodiments, the extension tube may include a loop.

In some embodiments, in response to movement of the actuator between theraised position and the depressed position with respect to the housing,the bump profile may progressively clamp the extension tube along theloop. In some embodiments, the loop may facilitate an increased fluidvolume flowing distally towards a catheter in response to movement ofthe actuator to the depressed position.

In some embodiments, in response to movement of the actuator between theraised position and the depressed position with respect to the housing,the bump profile may contact a distal portion of the loop prior tocontacting a proximal portion of the loop. In some embodiments, the bumpprofile may be configured to force fluid disposed within the loopdistally in response to movement of the actuator from the raisedposition to the depressed position.

In some embodiments, the housing may include one or more protrusions. Insome embodiments, the actuator may include one or more grooves. In someembodiments, the protrusions may be disposed within the grooves toorient the actuator within the housing. In some embodiments, theprotrusions and the grooves may prevent the actuator from rotating withrespect to the housing.

In some embodiments, the actuator may include a head, which may bedisposed outside the housing. In some embodiments, the head may contactan outer surface of the housing in response to movement of the actuatorto the depressed position. In some embodiments, the head of the actuatormay be disposed proximate a body of the actuator. In some embodiments, adiameter of the head may be greater than a diameter of the body. In someembodiments, the body may include the bump profile.

In some embodiments, the housing may include a distal opening and aproximal opening. In some embodiments, the extension tube may extendthrough the distal opening and the proximal opening. In someembodiments, the loop may be disposed between the distal opening and theproximal opening. In some embodiments, an interior of the housing mayinclude one or more support elements, which may be configured to contactthe extension tube to support the extension tube and maintain the loopin a loop configuration.

In some embodiments, the extension set may include a needlelessconnector coupled to the extension tube. In some embodiments, a cathetersystem may include the extension set and a catheter assembly. In someembodiments, the catheter assembly may include a catheter adapter and acatheter extending distally from the catheter adapter. In someembodiments, the extension tube may be coupled to the catheter adapter.

In some embodiments, a method of clamping the extension tube may includeplacing a first digit of a hand of a user on the actuator. In someembodiments, the first digit of the hand of the user may include athumb. In some embodiments, the method may include placing a seconddigit and a third digit of the hand of the user on a side of the housingopposite the actuator and the first digit. In some embodiments, themethod may include depressing the actuator with the first digit to movethe actuator to the depressed position. In some embodiments, in responseto depression of the actuator with the first digit, the bump profile mayprogressively clamp the extension tube along the loop.

The object and advantages of the embodiments will be realized andachieved at least by the elements, features, and combinationsparticularly pointed out in the claims. It is to be understood that boththe foregoing general description and the following detailed descriptionare exemplary and explanatory and are not restrictive of the invention,as claimed.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Example embodiments will be described and explained with additionalspecificity and detail through the use of the accompanying drawings inwhich:

FIG. 1A is a side view of a prior art clamp, illustrating the prior artclamp in an unactuated position, according to some embodiments;

FIG. 1B is another side view of the prior art clamp of FIG. 1A,illustrating the prior art clamp in an actuated position, according tosome embodiments;

FIG. 2 is an upper perspective view of an example catheter system,according to some embodiments;

FIG. 3A is an upper perspective view of an example clamp of the cathetersystem of FIG. 2, illustrating an example actuator of the clamp in araised position, according to some embodiments;

FIG. 3B is an upper perspective view of the clamp of FIG. 3A,illustrating the actuator in a depressed position, according to someembodiments;

FIG. 4A is a side view of the actuator of the clamp of FIG. 3A,according to some embodiments;

FIG. 4B is an opposite side view of the actuator of the clamp of FIG.3A, according to some embodiments;

FIG. 5A is an enlarged view of the clamp of FIG. 3A, illustrating theactuator in the raised position, according to some embodiments;

FIG. 5B is a top view of the clamp of FIG. 3A, illustrating the actuatorin the depressed position and an example head of the actuator removedfor illustration purposes, according to some embodiments;

FIG. 6A is a partial cutaway view of the clamp of FIG. 3A, illustratingthe actuator in the raised position, according to some embodiments;

FIG. 6B is another partial cutaway view of the clamp of FIG. 3A,illustrating the clamp in a partially depressed position, according tosome embodiments;

FIG. 6C is another partial cutaway view of the clamp of FIG. 3A,illustrating the clamp in the depressed position, according to someembodiments;

FIG. 6D is another partial cutaway view of the clamp of FIG. 3A,illustrating the clamp in the depressed position, according to someembodiments; and

FIG. 7 is an upper perspective view of an example extension set thatincludes the clamp of FIG. 3A, according to some embodiments.

DESCRIPTION OF EMBODIMENTS

Referring now to FIGS. 1A-1B, a prior art clamp 10 is illustrated. Anextension tube 12 may extend from a PIVC (not illustrated in FIGS.1A-1B) and through the prior art clamp 10. The extension tube 12 may beconnected and proximal to the PIVC. The prior art clamp 10 attempts toovercome connector-driven reflux by distally displacing fluid along agiven length of the extension tube 12 during clamping of the extensiontube 12. In further detail, in response to the clinician actuating theprior art clamp 10, the prior art clamp 10 acts to squeeze fluid out ofthe extension tube 12 in the vicinity of the prior art clamp 10,resulting in some clamp-driven positive displacement or net positiveoutput of fluid from the PIVC. However, the clamp-driven positivedisplacement may be relatively small.

Referring now to FIG. 2, an example catheter system 14 is illustrated,according to some embodiments. In some embodiments, the catheter system14 may include a catheter assembly 16. In some embodiments, the catheterassembly 16 may include a catheter adapter 18 and a catheter 20extending distally from the catheter adapter 18. In some embodiments,the catheter adapter 18 may include a side port 22 in fluidcommunication with the lumen of the catheter adapter 18. In someembodiments, the catheter adapter 18 may include a proximal end 23, adistal end 24, and a lumen extending there between. In some embodiments,the catheter 20 may include a PIVC.

In some embodiments, the catheter assembly 16 may be removably coupledto a needle assembly, which may include a needle hub 26 and anintroducer needle 28. In some embodiments, the introducer needle 28 mayinclude a sharp distal tip 30. In some embodiments, a proximal end ofthe introducer needle 28 may be secured within the needle hub 26. Insome embodiments, the introducer needle 28 may extend through thecatheter 20 when the catheter assembly 16 is in an insertion positionready for insertion into vasculature of a patient, as illustrated, forexample, in FIG. 2. In some embodiments, in response to the introducerneedle 28 being inserted into the vasculature of the patient, flashbackof blood may flow through the sharp distal tip 30 of the introducerneedle 28 and may be visible to a clinician between the introducerneedle 28 and the catheter 20 and/or at another location within thecatheter assembly 16.

In some embodiments, in response to confirmation via the blood flashbackthat the catheter 20 is positioned within vasculature of the patient,the needle assembly may be removed from the catheter assembly 16. Insome embodiments, when the needle assembly is coupled to the catheterassembly 16, as illustrated, for example, in FIG. 2, the introducerneedle 28 of the needle assembly may extend through a septum disposedwithin the lumen of the catheter adapter 18.

In some embodiments, the catheter system 14 may include an extension set32, which may include an extension tube 34 and a clamp 36. In someembodiments, a distal end of the extension tube 34 may be integratedwith the catheter adapter 18, as illustrated, for example, in FIG. 2.For example, the extension tube 34 may be integrated with the side port24 of the catheter adapter 18. In some embodiments, the extension tube34 may be removably coupled to the catheter adapter 18, as illustrated,for example, in FIG. 7. In some embodiments, the clamp 36 mayselectively close off the extension tube 16 to prevent blood or anotherfluid from flowing through the extension tube 16.

In some embodiments, the extension set 32 may include an adapter 38coupled to a proximal end of the extension tube 34. In some embodiments,the adapter 38 may include a Y-adapter or another suitable connector. Insome embodiments, a needleless connector 40 may be coupled to theadapter 38. In some embodiments, the adapter 38 and/or the needlelessconnector 40 may be used to connect the catheter 20 with a medicaldevice for fluid administration or blood withdrawal. The medical devicemay include a transfusion bag, syringe, or any other suitable medicaldevice. In some instances, the needleless connector 40 may reflux,meaning the needleless connector 40 may draw blood and fluid from thevasculature into the catheter 20 upon disconnection of the medicaldevice from the needleless connector 40. This connector-driven refluxmay not be desirable due to the increased potential for reduced catheterdwell times, which may result from clotting and occlusion within thecatheter system 14.

In some embodiments, the clamp 36 may facilitate positive displacementor net positive output of fluid from the PIVC. In some embodiments, inresponse to actuation of the clamp 36, fluid may be pushed out of theclamp 36 and into the catheter assembly 16, which may be connected tothe extension tube 34 and disposed distal to the clamp 36. The fluidthat is pushed out of the clamp 36 may be pushed into the catheter 20and into the patient.

In some embodiments, the clamp 36 may include a housing 42 and anactuator 44. In some embodiments, the housing 42 may be constructed ofmultiple pieces, which may be coupled together, or the housing 42 may bemonolithically formed as a single unit. Similarly, in some embodiments,the actuator 44 may be constructed of multiple pieces, which may becoupled together, or the actuator 44 may be monolithically formed as asingle unit. It is understood that the size, shape, and configuration ofthe housing 42 and/or the actuator 44 may vary.

Referring now to FIGS. 3A-3B, in some embodiments, the actuator 44 maybe movable between a raised position and a depressed position withrespect to the housing 42. The raised position is illustrated in FIG.3A, according to some embodiments. The depressed position is illustratedin FIG. 3B, according to some embodiments. In some embodiments, theclinician may move the actuator 44 to the depressed position to actuatethe clamp 36. In some embodiments, the actuator 44 may include a head45, which may be disposed outside the housing 42. In some embodiments,the head 45 may contact an outer surface of the housing 42 when theactuator 44 is in the depressed position. In some embodiments, the head45 may not contact the outer surface of the housing 42 when the actuator44 is in the depressed position.

In some embodiments, a method of clamping the extension tube 34 mayinclude placing a first digit of a hand of a user on the actuator 44, asillustrated, for example, in FIGS. 3A-3B. In some embodiments, the firstdigit of the hand of the user may include a thumb. In some embodiments,the method may include placing a second digit and a third digit of thehand of the user on a side of the housing 42 opposite the actuator 44and the first digit as illustrated, for example, in FIGS. 3A-3B. In someembodiments, the method may include pinching the clamp to depress theactuator 44 and move the actuator 44 to the depressed position. In someembodiments, in response to depression of the actuator 44 with the firstdigit, the bump profile may progressively clamp the extension tube 34along the loop.

Referring now to FIGS. 4A-4B, in some embodiments, the actuator 44 mayinclude a bump profile 46. In some embodiments, the head 45 of theactuator 44 may be disposed proximate a body 58 of the actuator 44. Insome embodiments, a diameter of the head 45 may be greater than adiameter of the body 58. In some embodiments, the body 58 may includethe bump profile 46. In some embodiments, the bump profile 46 mayinclude one or more ridges 47. For example, the bump profile 46 mayinclude a first ridge 47 a and a second ridge 47 b (which may bereferred to in the present disclosure as “ridges 47”). In someembodiments, the one or more ridges 47 may form a spiral or corkscrewshape on the body 58. In some embodiments, the bump profile 46 mayinclude one continuous ridge 47, which may form the spiral or corkscrewshape on the body 58.

In some embodiments, the spiral may include a curve that turns around anaxis at a constant distance from the axis while moving parallel to theaxis. In some embodiments, the curve may turn around the axis at aconstant angle such that a pitch of the spiral, or the height of thespiral along one complete turn of the spiral, would be constant. In someembodiments, the curve may turn around the axis at a variable angle suchthat the pitch of the spiral would be variable. In some embodiments, thecurve of the spiral may be mathematically optimized based oncharacteristics of a loop of the extension tube 34, such as a pitch ofthe loop.

Referring now to FIG. 5A-5C, in some embodiments, the extension tube 34of the extension set 32 may include the loop 48. In some embodiments, inresponse to movement of the actuator 44 between the raised position andthe depressed position with respect to the housing 42, the bump profile46 may progressively clamp the extension tube 34 along the loop 48. Insome embodiments, the loop 48 may facilitate an increased fluid volumeflowing distally from the clamp 36 towards the catheter 20 in responseto actuating the clamp 36.

In some embodiments, in response to movement of the actuator 44 betweenthe raised position and the depressed position with respect to thehousing 42, the bump profile 46 may contact a distal portion 50 of theloop 48 prior to contacting a proximal portion 52 of the loop 48. Insome embodiments, an overlap portion 49 of the 48 may be disposedbetween the distal portion 50 and the proximal portion 52. In someembodiments, the bump profile 46 may be configured to force fluiddisposed within the loop 48 distally in response to movement of theactuator 44 from the raised position to the depressed position. In someembodiments, the first ridge 47 a may be spaced apart from the secondridge 47 b to form a gap 51 that may be aligned with the overlap portion49.

In some embodiments, the housing 42 may include one or more protrusions54. In some embodiments, the actuator 44 may include one or more grooves56. In some embodiments, the protrusions 54 may be disposed within thegrooves 56 to orient the actuator 44 within the housing 42. In someembodiments, the protrusions 54 and the grooves 56 may prevent theactuator 44 from rotating with respect to the housing 42. In someembodiments, the housing 42 may not include the protrusions 54 and/orthe actuator 44 may not include the grooves 56. In these and otherembodiments, the first ridge 47 a and the second ridge 47 b may beconnected or continuous.

In some embodiments, the housing 42 may include a distal opening 60and/or a proximal opening 62. In some embodiments, the extension tube 34may extend through the distal opening 60 and/or the proximal opening 62.In some embodiments, the loop 48 may be disposed between the distalopening 60 and the proximal opening 62.

Referring now to FIGS. 6A-6D, in some embodiments, an interior of thehousing 42 may include one or more support elements 64, which may beconfigured to contact the extension tube 34 to support the extensiontube 34 and maintain the loop 48 in a loop configuration. In someembodiments, the support elements 64 may include grooves and/orprotrusions.

FIG. 6A is a partial cutaway view of the clamp 36, illustrating theactuator 44 in the raised position, according to some embodiments. Insome embodiments, when the actuator 44 is in the raised position, theone or more ridges 47 may not contact and/or pinch the extension tube34. In some embodiments, when the actuator 44 is in the raised position,the one or more ridges 47 may not contact and/or clamp the loop 48. Insome embodiments, when the actuator 44 is in the raised position, theone or more ridges 47 may not contact and/or clamp the distal portion 50and the proximal portion 52. In some embodiments, in response to aportion of the extension tube 34 being clamped or pinched, fluid may beprevented from flowing through the portion.

FIG. 6B is another partial cutaway view of the clamp 36, illustratingthe clamp 36 in a partially depressed position, according to someembodiments. In some embodiments, when the actuator 44 is in the raisedposition, one or more of the ridges 47 may clamp the distal portion 50but not the proximal portion 52. FIG. 6C is another partial cutaway viewof the clamp 36, illustrating the clamp in the depressed position,according to some embodiments. In some embodiments, when the clamp 36 isin the depressed position, both the distal portion 50 and the proximalportion 52 may be clamped by the one or more ridges 47. Thus, FIGS.6A-6C illustrate how the bump profile 46 may progressively clamp theextension tube 34 along the loop 48, according to some embodiments.

Referring now to FIG. 6D, another partial cutaway view of the clamp 36in the depressed position is illustrated, according to some embodiments.In some embodiments, in response to the actuator 44 moving from theraised position to the depressed position, an area of contact betweenthe ridges 47 and the extension tube 34 may rotate around acircumference of the actuator 44. In these embodiments, in response tothe actuator 44 moving from the raised position to the depressedposition, the area of contact between the ridges 47 and the extensiontube 34 may not increase in size, which may reduce an input forcenecessary to close the clamp 36.

In these and other embodiments, as illustrated in FIG. 6D, in responseto the actuator 44 moving from the raised position to the depressedposition, a portion of the one or more ridges 47, such as a portion ofthe second ridge 47 b, may move past the distal portion 50 and no longercontact and/or clamp the distal portion 50. In some embodiments, aportion of the one or more ridges 47 in contact with the extension tube34 may move past the extension tube 34 to no longer contact and/or clampthe extension tube 34 in response to movement of the actuator 44 fromthe raised position to the depressed position. In some embodiments, theone or more ridges 47 may form the spiral to progressively clamp and/ormove past the extension tube 34.

FIG. 7 is an upper perspective view of an example extension set 66 thatincludes the clamp 36, according to some embodiments. In someembodiments, a distal end 68 of the extension tube 34 may be coupled tothe side port 22 (illustrated, for example, in FIG. 2) via a connector70. In some embodiments, the connector 70 may include a luer adapter,such as, for example, a slip or thread male or female luer adapter. Insome embodiments, the connector 70 may include a non-luer adapter. Insome embodiments, the distal end 68 of the extension tube 34 may beintegrated with the connector 70.

All examples and conditional language recited herein are intended forpedagogical objects to aid the reader in understanding the invention andthe concepts contributed by the inventor to furthering the art, and areto be construed as being without limitation to such specifically recitedexamples and conditions. Although embodiments of the present inventionshave been described in detail, it should be understood that the variouschanges, substitutions, and alterations could be made hereto withoutdeparting from the spirit and scope of the invention.

1. An extension set, comprising: a clamp, comprising: a housing; and anactuator movable between a raised position and a depressed position withrespect to the housing, wherein the actuator comprises a bump profile;and an extension tube disposed within the housing, wherein the extensiontube comprises a loop, wherein in response to movement of the actuatorbetween the raised position and the depressed position with respect tothe housing, the bump profile progressively clamps the extension tubealong the loop.
 2. The extension set of claim 1, wherein the bumpprofile is configured to force fluid disposed within the loop distallyin response to movement of the actuator from the raised position to thedepressed position.
 3. The extension set of claim 1, wherein in responseto movement of the actuator between the raised position and thedepressed position with respect to the housing, the bump profilecontacts a distal portion of the loop prior to contacting a proximalportion of the loop.
 4. The extension set of claim 1, wherein thehousing comprises a protrusion, wherein the actuator comprises a groove,wherein the protrusion is disposed within the groove to orient theactuator within the housing.
 5. The extension set of claim 1, whereinthe actuator comprises a head disposed outside the housing, wherein thehead contacts an outer surface of the housing in response to movement ofthe actuator to the depressed position.
 6. The extension set of claim 5,wherein the head of the actuator is disposed proximate a body of theactuator, wherein a diameter of the head is greater than a diameter ofthe body, wherein the bump profile is disposed on the body.
 7. Theextension set of claim 1, wherein the housing comprises a distal openingand a proximal opening, wherein the extension tube extends through thedistal opening and the proximal opening, wherein the loop is disposedwithin the housing between the distal opening and the proximal opening.8. The clamp of assembly of claim 1, wherein an interior of the housingcomprises a support element configured to contact the extension tube tosupport the extension tube and maintain the loop in a loopconfiguration.
 9. The extension set of claim 1, further comprising aneedleless connector coupled to the extension tube.
 10. A cathetersystem, comprising: a catheter assembly, comprising: a catheter adapter;and a catheter extending distally from the catheter adapter; a clamp,comprising: a housing; an actuator movable between a raised position anda depressed position with respect to the housing, wherein the actuatorcomprises a bump profile; and an extension tube coupled to the catheteradapter, wherein the extension tube comprises a loop, wherein inresponse to movement of the actuator between the raised position and thedepressed position with respect to the housing, the bump profileprogressively clamps the extension tube along the loop.
 11. Theextension set of claim 10, wherein the bump profile is configured toforce fluid disposed within the loop distally in response to movement ofthe actuator from the raised position to the depressed position.
 12. Theextension set of claim 10, wherein in response to movement of theactuator between the raised position and the depressed position withrespect to the housing, the bump profile contacts a distal portion ofthe loop prior to contacting a proximal portion of the loop.
 13. Theextension set of claim 10, wherein the housing comprises a protrusion,wherein the actuator comprises a groove, wherein the protrusion isdisposed within the groove to orient the actuator within the housing.14. The extension set of claim 10, wherein the actuator comprises a headdisposed outside the housing, wherein the head contacts an outer surfaceof the housing in response to movement of the actuator to the depressedposition.
 15. The extension set of claim 14, wherein the head of theactuator is disposed proximate a body of the actuator, wherein adiameter of the head is greater than a diameter of the body, wherein thebump profile is disposed on the body.
 16. The extension set of claim 10,wherein the housing comprises a distal opening and a proximal opening,wherein the extension tube extends through the distal opening and theproximal opening, wherein the loop is disposed within the housingbetween the distal opening and the proximal opening.
 17. The clamp ofassembly 1, wherein an interior of the housing comprises a supportelement configured to contact the extension tube to support theextension tube and maintain the loop in a loop configuration.
 18. Amethod of clamping an extension tube, comprising: placing a first digitof a hand of a user on an actuator of a clamp of a extension set,wherein the first digit includes a thumb, wherein the extension setcomprises: a clamp, comprising: a housing; and the actuator movablebetween a raised position and a depressed position with respect to thehousing, wherein the actuator comprises a bump profile; an extensiontube comprising a loop; placing a third digit and a fourth digit of thehand of the user on a side of the housing opposite the actuator; anddepressing the actuator with the first digit to move the actuator to adepressed position with respect to the housing, wherein in response todepressing the actuator with the first digit, the bump profileprogressively clamps the extension tube along the loop.
 19. The methodof claim 18, wherein the bump profile is configured to force fluiddisposed within the loop distally in response to depression of theactuator.
 20. The method of claim 18, wherein in response to movement ofthe actuator between the raised position and the depressed position withrespect to the housing, the bump profile contacts a distal portion ofthe loop prior to contacting a proximal portion of the loop.